A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of RO7446603 Administered Alone or in Combination With Aflibercept or Faricimab in Participants With Diabetic Macular Edema
研究单位：[1]Genentech, Inc.[2]Barnet Dulaney Perkins Eye Center,Phoenix 5308655,Arizona 5551752,United States,85016[3]Arizona Retina and Vitreous Consultants,Phoenix 5308655,Arizona 5551752,United States,85020-5917[4]Associated Retinal Consultants PC,Phoenix 5308655,Arizona 5551752,United States,85020[5]Retinal Research Institute, LLC,Phoenix 5308655,Arizona 5551752,United States,85053[6]Retinal Diagnostic Center,Campbell 5333689,California 5332921,United States,95008[7]The Retina Partners,Encino 5346649,California 5332921,United States,91436[8]Retina Consultants of Orange County,Fullerton 5351247,California 5332921,United States,92835[9]Retinal Consultants Medical Group,Modesto 5373900,California 5332921,United States,95356-9412[10]Northern California Retina-Vitreous Associates,Mountain View 5375480,California 5332921,United States,94040[11]Retinal Consultants Medical Group,Sacramento 5389489,California 5332921,United States,95825[12]Macula Retina Vitreous Research Institute,Torrance 5403022,California 5332921,United States,90503-3270[13]Retina Consultants of Southern Colorado PC,Colorado Springs 5417598,Colorado 5417618,United States,80909[14]Retina Specialists of Colorado,Denver 5419384,Colorado 5417618,United States,80222[15]Advanced Vision Research Institute,Longmont 5579276,Colorado 5417618,United States,80503-6499[16]Retina Group of New England,Waterford 8480031,Connecticut 4831725,United States,06385-1215[17]Blue Ocean Clinical Research,Clearwater 4151316,Florida 4155751,United States,33761-2046[18]National Ophthalmic Research Institute,Fort Myers 4155995,Florida 4155751,United States,33912[19]Florida Retina Institute,Jacksonville 4160021,Florida 4155751,United States,32216-6347[20]Retina Associates of Florida[21]Retina Associates of Florida,Tampa 4174757,Florida 4155751,United States,33609[22]Southeast Retina Center,Augusta 4180531,Georgia 4197000,United States,30909-6440[23]Georgia Retina PC,Marietta 4207783,Georgia 4197000,United States,30060[24]Retina Consultants of Hawaii,‘Aiea 5856430,Hawaii 5855797,United States,96701[25]University Retina and Macula Associates, PC,Oak Forest 4904286,Illinois 4896861,United States,60452[26]Raj K. Maturi, MD PC,Indianapolis 4259418,Indiana 4921868,United States,46290[27]The Retina Care Center,Baltimore 4347778,Maryland 4361885,United States,21209[28]Johns Hopkins Hospital,Baltimore 4347778,Maryland 4361885,United States,21287[29]Retina Group of Washington,Chevy Chase 4351335,Maryland 4361885,United States,20815[30]Cumberland Valley Retina Consultants,Hagerstown 4357141,Maryland 4361885,United States,21740[31]Associated Retinal Consultants - Royal Oak,Royal Oak 5007804,Michigan 5001836,United States,48073[32]Retina Consultants Minnesota,Saint Louis Park 5045021,Minnesota 5037779,United States,55416[33]Long Island Vitreoretinal Consultants[34]Opthalmology,Hauppauge 5120228,New York 5128638,United States,11788[35]Retina Vitreous Surgeons of CNY PC,Liverpool 5124925,New York 5128638,United States,13088[36]Western Carolina Retinal Associate PA,Asheville 4453066,North Carolina 4482348,United States,28803[37]Duke University Medical Center,Durham 4464368,North Carolina 4482348,United States,27705[38]Graystone Eye,Hickory 4470778,North Carolina 4482348,United States,28602[39]North Carolina (NC) Retina Associates - Wake Forest Office,Wake Forest 4497290,North Carolina 4482348,United States,27587-3803[40]Piedmont Retina Specialists,Winston-Salem 4499612,North Carolina 4482348,United States,27103-6970[41]Cincinnati Eye Institute,Blue Ash 4506754,Ohio 5165418,United States,45242-5537[42]Ohio State Eye and Ear Institute,Columbus 4509177,Ohio 5165418,United States,43212[43]Tulsa Retina Consultants,Tulsa 4553433,Oklahoma 4544379,United States,74114[44]Cascade Medical Research Institute LLC,Springfield 5754005,Oregon 5744337,United States,97477[45]Erie Retina Research,Erie 5188843,Pennsylvania 6254927,United States,16505[46]Wills Eye Hospital,Philadelphia 4560349,Pennsylvania 6254927,United States,19107-5109[47]Sewickely Eye Group,Sewickley 5211506,Pennsylvania 6254927,United States,15143[48]Palmetto Retina Center,West Columbia 4600541,South Carolina 4597040,United States,29169-2429[49]Charles Retina Institute,Germantown 4624601,Tennessee 4662168,United States,38138[50]Retina Research Institute of Texas,Abilene 4669635,Texas 4736286,United States,79606[51]Texas Retina Associates,Arlington 4671240,Texas 4736286,United States,76012[52]Austin Retina Associates,Austin 4671654,Texas 4736286,United States,78705[53]Austin Clinical Research LLC,Austin 4671654,Texas 4736286,United States,78750[54]Retina & Vitreous of Texas,Bellaire 4673353,Texas 4736286,United States,77401[55]Texas Retina Associates,Dallas 4684888,Texas 4736286,United States,75231[56]Valley Retina Institute P.A.,McAllen 4709796,Texas 4736286,United States,78550-9207[57]Medical Center Ophthalmology Associates,San Antonio 4726206,Texas 4736286,United States,78240[58]Retina Consultants of Texas - San Antonio,San Antonio 4726206,Texas 4736286,United States,78240[59]Brown Retina Institute,San Antonio 4726206,Texas 4736286,United States,78251-4551[60]Retina Consultants of Texas,The Woodlands 4736476,Texas 4736286,United States,77384[61]Strategic Clinical Research Group, LLC,Willow Park 4742296,Texas 4736286,United States,76087[62]Retina Associates of Utah, PLLC[63]Clinical Research,Salt Lake City 5780993,Utah 5549030,United States,84107[64]Piedmont Eye Center,Lynchburg 4771075,Virginia 6254928,United States,24502-4271[65]Wagner Kapoor Institute,Norfolk 4776222,Virginia 6254928,United States,23502[66]Retina Institute of Virginia,Richmond 4781708,Virginia 6254928,United States,23235-1962[67]Spokane Eye Clinical Research,Spokane 5811696,Washington 5815135,United States,99204[68]Beijing Tongren Hospital, Capital Medical University,Beijing 1816670,Beijing Municipality 2038349,China,100730[69]Tianjin Medical University Eye Hospital,Tianjin 1792947,Tianjin Municipality 1792943,China,300384[70]Eye Hospital,WMU(Zhejiang Eye Hospital),Wenzhou 1791388,Zhejiang 1784764,China,325027[71]Beijing Hospital,Beijing 1816670,China,100730[72]Peking Union Medical College Hospital,Beijing 1816670,China,100730[73]Shanghai General Hospital - North Campus,Shanghai 1796236,China,200080[74]Emanuelli Research and Development Center LLC,Arecibo 4562635,Puerto Rico,00612
研究目的：
This study aims to evaluate the ocular and systemic safety, tolerability and efficacy of RO7446603 in participants with diabetic macular edema (DME). The study consists of 2 segments: Phase I (Parts 1-4) and Phase II (Part 5). Phase I investigated the safety of RO7446603 following a single and multiple intravitreal (IVT) doses as monotherapy or co-administered with IVT aflibercept or IVT faricimab (in separate injections). Phase II will investigate the safety, tolerability, pharmacokinetics (PK) and efficacy of two dose levels of RO7446603 in combination with faricimab, with the two drugs co-mixed and administered as a single IVT injection, compared to faricimab alone. The first participant was enrolled in the Phase I segment on June 22, 2022. Phase I has been completed.
